For the IVDD 98/79/EC directive, the Declaration of Conformity should be signed by the most responsible person in the organisation and/or that individual that is responsible for the regulatory compliance of the product. It could be the Regulatory Manager, the site director, the President/CEO, etc. The current IVDD does not specify who signs, but in the future, the In Vitro Diagnostic Regulatiion (IVDR) EU 2017/746 makes it clear in Annex IV who signs: 'Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.' Well it still does not specify who should sign, but we are recommending that the Person Responsible for Regulatory Compliance from Article 15 is that individual since they will be responsible for the regulatory compliance of the QMS and product.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 06-Mar-2019 05:17
From: Anonymous Member
Subject: IVDD EC DOC
This message was posted by a user wishing to remain anonymous
Hi collegues,
I would like to know who is responsible for signing on IVDD EC DOC format ?
Site director ? President/CEO ? R&D Head ?
In addition, please let me know for which article/regulation refer to ?
Thanks for your kind cooperation.